On Tuesday the FDA approved Vivus' weight loss drug Qsymia (formerly called Qnexa). This is wonderful news and it will no doubt benefit many American patients. However, let's be clear on what really happened.
The Qsymia family consists of four fixed-dose combinations of immediate-release phentermine hydrochloride and extended-release topiramate. Phentermine hydrochloride has been on the market since the early 1970's and Topamax (topiramate) was approved in 1996. Some physicians have been prescribing a combination of phentermine and topiramate off-label for years, although the doses are probably different that those of Qsymia.
While I am excited and encouraged that the FDA approved Qsymia, what it really did was simply allow Vivus to promote Qsymia, which is a combination of two existing drugs. Let's use an analogy to make this clear.
Imagine that phentermine is chocolate and topiramate is peanut butter and the FDA had previously approved chocolate for consumption alone or in combination with red wine. The FDA also approved peanut butter on crackers and in combination with jelly and bread in PB&J sandwiches. Someone comes along and discovers that chocolate and peanut butter are delicious together. Because both foods have been approved, anyone can mix and eat the two together, although they might botch the proportions or get the serving size wrong.
Along comes Reece's which wants to manufacture and sell peanut butter cups. In our analogy, Reece's can manufacture all the peanut butter cups it wants, but it can't promote them without approval, meaning it shouldn't plan on manufacturing a lot.
To summarize, individual consumers can make their own homebrew Qsymia (peanut butter cups). Physicians can prescribe and therefore promote homebrew Qsymia (peanut butter cups). But without the FDA's explicit approval, Vivus cannot market Qsymia (peanut butter cups). What would we think if Reese's had to run the FDA's approval gauntlet to market peanut butter cups?
Oh, but you say, Qsymia might be harmful to some patients while peanut butter cups are just food. That's not true. Both chocolate and peanuts can cause severe allergies in certain people and can trigger migraines. Approximately 1.8 million Americans suffer from peanut allergies and some number die each year from anaphylactic reactions.
So we can safely assume that if Reese's tried to secure the FDA's approval before marketing Reese's Peanut Butter Cups, it would fail and peanut butter cups would not be available in your grocery store. I, for one, am glad that peanut butter cups are not subject to premarketing approval.